科兴疫苗紧急使用放宽至三岁以上

(北京5日讯)中国科兴控股生物技术有限公司的董事长尹卫东在昨天的一档节目中说,科兴中维有一个叫未成年人人群的临床研究,在今年年初就已经启动,目前已经完成了一期临床和二期临床,有数百人临床研究表明,儿童组(3岁-17岁)接种疫苗之后,它的安全性是良好的,抗体水平也和成年人是一样的。现在中国已经批准科兴冠病疫苗紧急使用的年龄范围扩大到三岁以上。

根据央视新闻客户端消息,尹卫东说,不过疫苗什么时候在更低的年龄组使用,将由国家卫健委组织有关专家,根据中国现在疫情需要和人群构成,有秩序推动不同年龄组的疫苗使用。

科兴中维进入世卫组织紧急使用清单,是获得的第47个紧急使用,在此之前科兴已经在中国之外的46个国家获得了紧急使用。这意味着能够符合更多国家的生产质量标准,同时也能为更多国家提供疫苗。有很多国家自身不具备疫苗审评的基础和条件,所以会接受世卫组织的认证,就可以进行采购;还有一点更重要的就是一些国际组织,比如COVAX全球冠病疫苗计划,通过这样的论证来进行采购,对于科兴来讲,意味着向更多国家更大范围的提供疫苗。

在设计疫苗产能的时候,已经考虑到中国的需要和全球需要,目前科兴中维的设计产能是年产20亿。但是根据今年上半年的情况看,产能已经超过了设计产能。“我们现在已经向全球提供了超过6亿多剂的疫苗,也就是说我们已经具备了向世卫组织和更多国家提供疫苗的质量标准和产量准备和产能的更进一步提升的条件。 ”

新闻来源:南洋商报


接种第3针灭活疫苗 中国科兴:抗体可提升10倍

(北京5日综合电)中国科兴生物技术公司董事长尹卫东周六指,最近已经完成了二期临床研究,打完两针剂次的志愿者,在隔3个至月6个月之后接种第3针,抗体可以迅速地在一周内跳到10倍,半个月就可以达到20倍。他指,现在中国的灭活疫苗,两针完成免疫以后,在体内已经建立起免疫记忆。

但是研究人员需要在真实世界的研究过程中观察,2针疫苗持续保护效果有多长。尹卫东说,现在就中国来讲,其实完成2针免疫,是对所有的公众最重要的工作,什么时候需要第3针,需要给研究人员一段时间,以在半年、一年进行详细的研究测试,再决定应该在什么时候加强第3针。

新闻来源: 中国报 


Sinovac says its vaccine is safe for children as young as 3

TAIPEI, Taiwan (AP) — Sinovac said its COVID-19 vaccine is safe in children ages 3-17, based on preliminary data, and it has submitted the data to Chinese drug regulators.

More than 70 million shots of Sinovac’s vaccine have been given worldwide, including in China.

China has approved its use in adults but it has not yet been used in children, because their immune systems may respond differently to the vaccine. Early and mid-stage clinical trials with over 550 subjects showed the vaccine would induce an immune response, Gang Zeng, the medical director at Sinovac, said at a news conference Monday.

“Showing that the vaccine is safe and would elicit potentially useful immune response against SARS-CoV-2 is very welcomed,” said Eng Eong Ooi, a professor at the Duke NUS Medical school in Singapore.

Children are far less likely to be seriously ill with COVID-19, but they are still at risk and can spread the virus. And while vaccination campaigns worldwide have focused on adults, children will need to be immunized to end the pandemic.

The Pfizer vaccine is cleared for use starting at age 16 and is being studied in ages 12-16. Moderna has been studying its vaccine in children aged 12 and older, and last week announced a new study testing its use in children younger than 12.

State-owned Sinopharm, who has two COVID-19 vaccines, is also investigating the effectiveness of its vaccines in children. The company said in January it had submitted clinical data to regulators.

Source: APPNEWS March 23, 2021

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